2020-SSJ-Hamer_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID#36C250-26-AP-3437

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO 12 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C250-26-AP-3437

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction:

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Network Contracting Office (NCO) 10 intends to award a new firm-fixed-price, sole source purchase order to Johnson & Johnson-DePuy Synthes, for Actis Broach Case Trays for the Cle VAMC.

ESTIMATED DOLLAR VALUE: $225,985.50

REQUIRED DELIVERY DATE: 30 Days ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The ACTIS Total Hip System instrumentation and broach trays are proprietary to DePuy Synthes and are specifically designed for use with the ACTIS femoral stem system utilized by the Cleveland VA Medical Center. The instrumentation incorporates ACTIS-specific broaches, reamers, trial necks, inserters, and sizing components engineered to match the geometry, sizing, alignment, and implantation requirements of the ACTIS Total Hip System.

The ACTIS system is designed to support tissue-sparing surgical approaches and includes specialized instrumentation intended to support proper implant positioning, alignment, rotational stability, and restoration of leg length and offset during total hip arthroplasty procedures. Use of non-compatible instrumentation could negatively impact implant compatibility, surgical workflow, procedural efficiency, and patient outcomes.

Additionally, DePuy Synthes confirmed it does not utilize authorized distributors for this requirement. Therefore, no other source can provide the required proprietary ACTIS

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID#36C250-26-AP-3437 instrumentation and associated surgical trays necessary to support the Government’s existing ACTIS Total Hip System.

1. Description of market research conducted and results or statement why it was not conducted: Market research was conducted by the Contracting Officer and the Service to determine if there were other vendors capable of providing case trays that meet CLE VAMC's specific requirements. The following sources were reviewed:

5/26/2026 GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, MSVP, BIC, and FDA were reviewed:

o Keywords Used: "case trays” o Results: No results identified for the required ACTIS broach trays and associated instrumentation.

On 5/26/2026 SBS was reviewed:

o NAICS Code Searched: 339112 o Keywords Used: "case trays" o Results: SBS was queried, as required, using NAICS 339112, in which the search provided 0 result.

The NMR does apply to this procurement under NAICS 339112. The VA and SBA Rule of Two cannot be met, due to being sole sourced to Johnson & Johnson- DePuy Synthes, as large business open market.

4. Contracting Officer's Certification: Purchase is approved in accordance with RFO 12. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Rachelle J. Hamer Contracting Officer

NCO 10

RACHELL

E HAMER

Digitally signed by

RACHELLE HAMER

Date: 2026.05.26 14:55:08 -04'00'